EASYCARE ONLINE

Ventilator, Continuous, Non-life-supporting

RESMED LTD.

The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Easycare Online.

Pre-market Notification Details

Device IDK123557
510k NumberK123557
Device Name:EASYCARE ONLINE
ClassificationVentilator, Continuous, Non-life-supporting
Applicant RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego,  CA  92123
ContactJim Cassi
CorrespondentJim Cassi
RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego,  CA  92123
Product CodeMNS  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-19
Decision Date2013-03-14
Summary:summary

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